Medtronic SynchroMed Pump Problems Linked to Unapproved Drugs

Irvin Jackson

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Medtronic is warning that its SynchroMed II and SynchroMed EL pumps are failing at a high rate, indicating that the problems are occurring because of the use of unapproved drugs in the infusion pumps. 

In an Urgent Medical Device Safety Notification sent to doctors last month, Medtronic warned that the use of drugs not approved for use with the SynchroMed infusion pumps could cause motors to stall.

The FDA has declared the action to be a Medtronic SynchroMed Infusion Pump recall and has given the action a Class I medical device recall designation, even though the pumps are still on the market. Class I recalls are the most serious classification of recall and means the FDA believes the devices could cause severe injury or death due to the problem.

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According to Medtronic, the normal failure rate of its SynchroMed infusion pumps is 2.4% after 6.5 years of use. When unapproved drugs are used in the device, the failure rate jumps to 7%. However, Medtronic indicates that there have been no deaths linked to the Synchromed pump problems.

In July, the FDA sent a warning letter to Medtronic over the infusion pumps, ordering the company to put in place a plan to deal with reported failure problems. The FDA had received 567 complaints about motor corrosion in the SynchroMed II pump between then and October 2007. The corrosion caused gears to lose teeth, which lead to the motor seizing up.

Drugs approved for use in the SynchroMed infusion pumps include Infumorp, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen. The FDA and Medtronic are warning customers not to use any compounded drugs, unapproved concentrations or unapproved formulations with these pumps.

The Medtronic SynchroMed Infusion Pump line has been plagued by problems over the last couple of years. In February 2011, the FDA declared a Class I recall for Synchromed pumps following reports that doctors were accidentally injecting drugs directly into patients’ subcutaneous tissues while attempting to refill the devices. These “pocket fills” resulted in at least eight deaths and 270 injuries requiring medical intervention.

In September of last year, a Synchromed II battery recall was announced after the company received reports of batteries becoming covered with a thin film and failing. It too received a Class I recall designation.

Irvin Jackson
Written by: Irvin Jackson

Senior Legal Journalist & Contributing Editor

Irvin Jackson is a senior investigative reporter at AboutLawsuits.com with more than 30 years of experience covering mass tort litigation, environmental policy, and consumer safety. He previously served as Associate Editor at Inside the EPA and contributes original reporting on product liability lawsuits, regulatory failures, and nationwide litigation trends.

Tags: Infusion Pump, Medtronic, Synchromed Pump

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7 Comments

BRENDA
Sept.19 2018 I had a Pain Pump installed with Prialt for Back pain. In Nov, I was hospitalized because of the Pain pump and the Prialt . For almost three month I went through pure HELL,I was hospitalized all of this time. I am now at home and my husband has to take care of me. I cant remember a lot of things. I would never wish this on anyone! PRIALT IS A DRUG FROM HELL.MEDTRONIC PAIN PUMPS are no better.
Brake
DO NOT use this drug! I’ve had two pain pumps over the last ten years at the age of 47. I have severe idiopathic peripheral neuropathy. I only use dilaudid nowadays in my pump and no oral opioids or patches. My Pain management PA was so Gung Ho about this medicine. When we first added Prialt in my pump I could barely walk in a straight line. Memory problems, slurred speech, and difficulty walking over several months. I had a dilaudid/Prialt combination for years set at a very low rate (1.6 mcg). After 6 years my goal was to remove the pain pump after quitting all my oral opioids. We titrated as low as u could go which was .6mcg I believe. Two weeks later she pulled all the medicine out and ran saline but on the thirteenth day my hands turned beat red and my neuropathic pain flared severly to a 10. Literally tears were uncontrollable. My neuropathic pain was constant and I couldn’t concentrate on anything else but pain. I went to the ER almost everyday for a month to get a dilaudid shot to make it through the day. She replaced the Prialt on the first week and still experienced neuropathic burning. She finally removed it and then inserted just the dilaudid. Two days later I had pain relief and it got better everyday. I have to girls and each day wondered what they would think if I couldn’t take the pain any longer. I didn’t want to live because the pain was off the charts!!! I believe this medicine was the reason I failed in my goal to remove my pump. I’ve had my second pump for two years now and I plan to one day try again. I believe I can succeed since the Prialt hasn’t been in my system in over two years. Horrible drug!
Jeanie
Please never let any Dr. convince you to use prialt. I ended up unresponsive & spent 7 days in the hospital. Nightmares, hallucinations, paranoia, anxiety, music constantly in my head, can not remember the 8 months prior to prialt. 3 1/2 years later all symptoms are still there, can’t even have a tv on in the house because my mind thinks I’m being watched. I am a shell of who I used to be. The worst part both my neurosurgeon & pain Dr. dumped me like a hot potato when this happened.
ann
I have RRMS and used prialt for pain. i suffered a severe case of psychosis. I went to four different hospitals, pych. units. The doctor finally figured it was the prialt. took 2-3 weeks before I felt better. wont use prialt in my pain pump again.
Kim
I to was treated with Prialt with a pump. It was horrible for 63 days I kept telling them it was the pump. They wouldn’t listen to me. I had a severe reaction with loss of memory and sever pain. The leads were place backwards and were placed on a nerve so there was sever sciatica pain. Finally went to anther hospital and was showing signs of such a severe reaction to the iodine in the Prialt that I was hardly breathing. Then they took it out and punched my spinal cord. Overnight when I got to bed I woke at 430 am with a soaked bed. My spinal fluid leaked out very bad threw out the night. Next morning surgery to repair the leak. I’m scared to death to get another percedure of any kind. I will only take pills.
Concerned
Prialt should be banned! I have a Medtronic infusion pump and was treated with Prialt. I was 44 years old (female) and began to have memory problems which I reported to my physician’s assistant. I went through this for months. Then I began to have trouble swallowing until I could only eat soft foods. I was rushed to the ER when I began to feel strange feelings over my head and numbness in my face and on my right side. I was admitted into the stroke unit. I kept telling the doctors to call in my Medtronic rep or pain doctor (who was out of town) so they could shut the damn pump off. I knew what it was!!! It took 12 hours, but the pump rep finally showed up, although ticked off because it was Saturday while also bringing his children into my room, but, it was the Prialt. The symptoms gradually decreased , but my memory has been horribly impaired. Pretty sad when I was always complimented on my ability to recall the pedigrees of the show dogs I use to be able to show or memories from my childhood. So much is gone and there’s times I feel so stupid when I can’t remember a word I should easily be able to recall. Please!!!! DO NOT LET YOURSELF BE TREATED WITH THIS POISON!!!
Bill
Worst drug on the market. Only on the market to try to do away with opiates.

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